NCT04396158

Brief Summary

Thyroid carcinoma is the most common endocrine malignancy. Surgery is the standard therapeutic approach for patients with differentiated thyroid carcinoma (DTC), followed by radioiodine (RAI) therapy if indicated. For women with DTC, the effects of RAI therapy on gonadal and reproductive function are an important consideration. This study aimed to evaluate the effects of RAI therapy on ovarian function.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 16, 2020

Last Update Submit

May 22, 2020

Conditions

Ovarian InsufficiencyRadiation Exposure

Outcome Measures

Primary Outcomes (1)

  • Level of anti-Müllerian (AMH) hormone

    Level of anti-Müllerian (AMH) hormone in female patients before and after radioactive iodine therapy.

    6 months

Study Arms (1)

intervention

EXPERIMENTAL
Radiation: radioactive iodine

Interventions

radioactive iodineRADIATION

80-200 mCi of radioactive iodine will be given to thyroid cancer patients

intervention

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female patient in childbearing period.
  • Female patient with differentiated thyroid carcinoma.
  • Underwent thyroidectomy.
  • Candidate for radioactive iodine therapy.

You may not qualify if:

  • Male patients.
  • Postmenopausal female patients.
  • Female patients with undifferentiated thyroid carcinoma.
  • Pregnant female patients.
  • Lactating female patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: self controlled case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of nuclear medicine

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 20, 2020

Study Start

June 15, 2020

Primary Completion

June 15, 2021

Study Completion

December 15, 2021

Last Updated

May 27, 2020

Record last verified: 2020-05